BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKN JOURNEY BCS / JOURNEY II BCS KNEE

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·November 17, 2023

    UNKN JOURNEY BCS / JOURNEY II BCS KNEE

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·November 17, 2023

    UNKN GENESIS II TOTAL KNEE IMPL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDG·November 17, 2023

    RANDOX CARBAMAZEPINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INTRASTENT DOUBLESTRUT PARAMOUNT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DEPUY ASR XL FEM IMP SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 16, 2013

    ACCU-CHEK ULTRAFLEX INFUSION SET

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code FPA·June 17, 2008

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 18, 2011

    UNKN GENESIS II TOTAL KNEE IMPL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDG·November 17, 2023

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·February 19, 2026

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024